NCT03001362 Patients With Rectal Cancer: a "Wait-and-see" Approach
| NCT ID | NCT03001362 |
| Status | Recruiting |
| Phase | — |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre |
| Condition | Colorectal Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2015-03 |
| Primary Completion | 2025-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 48 participants in total. It began in 2015-03 with a primary completion date of 2025-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Patients with histologically proven adenocarcinoma of the rectum will receive pelvic radiotherapy to a dose of 45Gy in 25 fractions with a tumor boost to a dose of 9Gy in 5 fractions (thus total of 54Gy/30Fx to the primary tumor), combined with radio sensitizing chemotherapy. Patients will then be closely monitored, through endoscopy and imaging, for response to treatment and relapse. Salvage oncologic surgery to be offered if there is failure to achieve complete clinical response or in the event of a loco regional relapse.
Eligibility Criteria
Inclusion Criteria: * Pelvic MRI defined disease (at least one of the following): * mesorectum involved or breached - includes involvement of adjacent organ (s) (T3-T4) * involvement of muscularis propria (T2) * extra-mural vascular invasion * tumour deposit within the mesorectum * one or more involved mesorectal lymph node * Patients are considered medically fit for oncologic resection * ECOG performance status 0 or 1 * No evidence of established metastatic disease (CT chest and abdomen) * Absolute neutrophil count \>1.5x109/L; platelets \>100x109/L, * Serum transaminase \<3 x ULN; * Adequate renal function (Cockroft Gault estimation \>50 mL/min) * Bilirubin \<1.5 x ULN * Ability to comply with oral medication * Willingness and ability to give informed consent and comply with treatment and follow up schedule * Age 18 or over Exclusion Criteria: * Previous radiotherapy to the pelvis (including brachytherapy) * Enlarged extramesorectal nodes * Uncontrolled cardiorespiratory comorbidity (includes patients with inadequately controlled angina or myocardial infarction within 6 months of randomisation) * T1N0 disease without extra-mural venous invasion * Unequivocal evidence of metastatic disease (includes resectable metastases) * Major impairment of bowel function without defunctioning stoma/ileostomy (baseline grade 3 diarrhoea or clinically significant faecal incontinence) * History of another malignancy within the last 5 years except successfully treated basal cell cancer of skin or carcinoma in situ of uterine cervix. * Known dihydropyrimidine dehydrogenase deficiency * Known Gilberts disease (hyperbilirubinaemia) * Taking warfarin or phenytoin or sorivudine * Gastrointestinal disorder which would interfere with oral therapy and its bioavailability * Pregnant, lactating, or pre-menopausal women not using adequate contraception * Unfit to receive any study treatment or subsequent surgical resection
Contact & Investigator
Neil Kopek, M.D.
PRINCIPAL INVESTIGATOR
Radiation Oncologist
Frequently Asked Questions
Who can join the NCT03001362 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Colorectal Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03001362 currently recruiting?
Yes, NCT03001362 is actively recruiting participants. Contact the research team at neil.kopek@muhc.mcgill.ca for enrollment information.
Where is the NCT03001362 trial being conducted?
This trial is being conducted at Montreal, Canada, Montreal, Canada.
Who is sponsoring the NCT03001362 clinical trial?
NCT03001362 is sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. The principal investigator is Neil Kopek, M.D. at Radiation Oncologist. The trial plans to enroll 48 participants.